Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00063986

Purpose

RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.

Condition	Intervention	Phase
Esophageal Cancer	Procedure: laparoscopic surgery Procedure: thoracoscopic surgery	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Mortality at 30 days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity [ Designated as safety issue: No ]
Rate of conversion to open operation [ Designated as safety issue: No ]
Effectiveness of lymph node dissection [ Designated as safety issue: No ]
Duration of operating time [ Designated as safety issue: No ]
Length of intensive care unit stay and hospital stay [ Designated as safety issue: No ]
Survival at 3 years [ Designated as safety issue: No ]
Tumor recurrence [ Designated as safety issue: No ]
Dysphagia [ Designated as safety issue: No ]
Home status (i.e., home vs resident in care facility) [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	March 2004
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer.
Determine the complications associated with this procedure in these patients.
Determine the rate at which conversion to open operation is required in patients undergoing this procedure.
Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.
Determine feasibility and conversion rate of MIE after neoadjuvant therapy.
Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.
Assess outcomes at follow-up to three years.

OUTLINE: This is a multicenter study.

Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 35-105 patients will be accrued for this study within 9-27 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:
- Histologically confirmed esophageal cancer
  - Stages I-III (T1-3, N0-1)
  - No M1 disease
- High-grade dysplasia of the esophagus
Must have a requirement for esophagectomy and be considered an appropriate candidate
Stomach must be available for conduit (no cancer extending into the stomach more than 20%)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Creatinine less than 2 mg/dL

Other

Prior malignancy allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No more than 5 months since prior neoadjuvant chemotherapy (patients with esophageal cancer only)

Endocrine therapy

Not specified

Radiotherapy

No more than 5 months since prior neoadjuvant radiotherapy (patients with esophageal cancer only)

Surgery

See Disease Characteristics
No prior anti-reflux or gastric operations
No prior right thoracotomy
No prior major neck operation other than the removal of superficial skin lesion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063986

Show 41 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Study Chair:	James D. Luketich, MD	University of Pittsburgh
Study Chair:	David J. Sugarbaker, MD	Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00063986 History of Changes
Other Study ID Numbers:	CDR0000305866, ECOG-E2202, CALGB-140302
Study First Received:	July 8, 2003
Last Updated:	April 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012